MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH; MIDLINE CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regq2381 showed two other similar product complaint(s) from this batch number.

Event Description

It was reported by the customer "peeling of introducer upon insertion.Opened second kit and was able to place introducer without difficulty." (b)(6) 2023.Additional information provided: no patient harm reported.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of the introducer peeling upon insertion is confirmed and was determined to be due to an unknown cause.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation showed blood use residues throughout the microintroducer.There were no obvious sharp bends observed on the returned device, but the distal tip of the gray sheath appeared deformed.A microscopic observation revealed the entire distal tip of the gray sheath to be deformed and pushed towards the proximal end of the microintroducer.Nothing remarkable was observed throughout the rest of the complainant device.The complaint of peeling the microintroducer upon insertion of the device is confirmed.Due to the extent of the deformation, a cause cannot be established as the microintroducer had abundant use residues and deformation to the distal tip of the gray sheath.Possible causes may be angle of insertion of the device or a sharper taper angle due to the manufacturing process of the device.

Event Description

It was reported by the customer "peeling of introducer upon insertion.Opened second kit and was able to place introducer without difficulty." 01/24/2023 additional information provided: no patient harm reported.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16275056
• MDR Text Key: 308836224
• Report Number: 3006260740-2023-00292
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REGQ2381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 69 KG